Comparison of Olanzapine and Metoclopramide For Treatment Of bReakThrough Emesis

Efficacy of Olanzapine in Break-through Emesis After Prophylaxis With Dexamethasone, 5-HT3 Receptor Antagonists and Aprepitant Compared to Metoclopramide

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01148264

Acronym

COMFORT

Enrollment

Registered

2010-06-22

Start date

2010-07-31

Completion date

2014-10-31

Last updated

2016-05-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Emesis

Keywords

break-through, emesis, break through emesis after prophylaxis with dexamethasone, 5-HT 3RA and aprepitant

Brief summary

This trial is designed to evaluate olanzapine compared to the metoclopramide in the treatment of break through emesis after prophylaxis with dexamethasone, 5-HT 3 receptor antagonists and aprepitant in patients receiving chemotherapy. Efficacy will be assessed using a modified MASCC questionaire with a visual analog scale.

Interventions

DRUGolanzapine

1x10mg per day for three days

DRUGmetoclopramide

3x10mg per day for three days

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* break through emesis after prophylaxis with dexamethasone, 5-HT 3 receptor antagonists and aprepitant in patients receiving chemotherapy defined as vomitus or nausea\>25mm on VAS * signed IC

Exclusion criteria

* psychiatric disorders * drug abuse * pregnancy * high dose chemotherapy * treatment with other antiemetic drugs

Design outcomes

Primary

Measure	Time frame	Description
Clinical benefit rate	three days	no vomitus, no further rescue medication, nausea \< 25mm on the visual analog scale (VAS) or reduction on the VAS of \>50%

Secondary

Measure	Time frame	Description
safety	five days	according to NCI-CTC-AE version4.0
Quality of life	5 days	using EORTC-QLQ-C30
change in urinary excretion of 5 hydroxy indole acetic acid	5 days	measurement in 24 hours urine samples

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026